Clinical Outcome Assessment for AT & BCI

Official title

Development of a Clinical Outcome Assessment for Assistive Technologies and Brain-Computer-Interfaces

Overview

Many individuals with severe motor impairments rely on Assistive Technologies (ATs) or Brain-Computer Interfaces (BCIs) to interact with digital devices such as their computers. Clinicians and researchers currently lack a common framework to objectively quantify how much a given AT or BCI improves real-world function or to compare across tools. This project seeks to address this gap by developing a standardized method to objectively assess or compare the functional benefit of these tools on digital independence, i.e., the ability to independently operate computers, phones, and other digital systems, by creating a unique Digital Assessment Interface (DAI). This assessment will be a simulation of online and digital activities that prior work has determined is important to functional daily living in the digital domain. Participants will complete this assessment with various ATs and BCIs, and these scores will be used to create an index, which will be comprised of performance outcomes, clinician-reported outcomes, and patient-reported outcomes. The tool aims to quantify and compare digital task performance across devices and user populations. The primary objective of this study is to develop an index. The index will quantify functional performance of individuals using various ATs and BCIs. The secondary objectives are to extensively evaluate the psychometric properties of the index, such as the validity, responsiveness, reliability, and floor/ceiling effects both globally and across different devices and impairment levels, ensuring that it can reliably measure the impact of an AT or BCI on a user's ability to independently operate digital systems; and to characterize the familiarization and use of specific BCI and AT systems with reference to a normative healthy control population.

Interventions

• Device Eye Tracker
  The intervention consists of two 40-minute training sessions using a customized Digital Training Interface to practice motor primitives for digital activities (clicking, typing, scrolling, drawing). The first session includes an orientation to the eye-tracking device, calibration, and setup adjustments, after which the clinician will confirm feasibility. Training begins with a guided tutorial followed by eight practice levels, each lasting 3 minutes or until 20 correct targets are achieved. Part
• Device Mouth Operated Joystick
  The intervention consists of two 40-minute training sessions using a customized Digital Training Interface to practice motor primitives for digital activities (clicking, typing, scrolling, drawing). The first session includes an orientation to the mouth-operated joystick device, calibration, and setup adjustments, after which the clinician will confirm feasibility. Training begins with a guided tutorial followed by eight practice levels, each lasting 3 minutes or until 20 correct targets are ach
• Device Non-invasive electroencephalogram (EEG) Headset
  The intervention consists of two 40-minute training sessions using a customized Digital Training Interface to practice motor primitives for digital activities (clicking, typing, scrolling, drawing). The first session includes an orientation to the non-invasive EEG headset device, calibration, and setup adjustments, after which the clinician will confirm feasibility. Training begins with a guided tutorial followed by eight practice levels, each lasting 3 minutes or until 20 correct targets are ac
• Device Implantable Brain-Computer-Interface
  Participants with an invasive Brain Computer Interface (BCI) implant, primarily recruited via Neuralink, will use the Neuralink N1 or any other implanted BCI. The intervention consists of one 40-minute training session using a customized Digital Training Interface to practice motor primitives for digital activities (clicking, typing, scrolling, drawing). The session begins with setup assistance and calibration to ensure proper positioning. Training includes a guided tutorial followed by eight pr
• Device Personal Assistive Technology
  Participants already using a personal assistive technology device will complete one 40-minute training session with a customized Digital Training Interface to practice motor primitives for digital activities (clicking, typing, scrolling, drawing). The session begins with setup assistance and positioning. Training includes a guided tutorial followed by eight practice levels, each lasting 3 minutes or until 20 correct targets are achieved. Participants are encouraged to complete all levels and foc
• Device Voice Control
  The intervention consists of two 40-minute training sessions using a customized Digital Training Interface to practice motor primitives for digital activities (clicking, typing, scrolling, drawing). The first session includes an orientation to voice control, after which the clinician will confirm feasibility. Training begins with a guided tutorial followed by eight practice levels, each lasting 3 minutes or until 20 correct targets are achieved. Participants are encouraged to complete all levels

Primary outcome measures

• Performance Outcomes (PerfOs) [Time frame: Through study completion, every visit during the Digital Assessment Interface.]
• Demographics and Medical Intake Questionnaire [Time frame: Day 1]
• NASA Task Load Index [Time frame: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.]
• NASA Task Load Index - Clinician's perspective [Time frame: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.]
• System Usability Scale (SUS) [Time frame: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.]
• System Usability Scale (SUS) - Clinician's perspective [Time frame: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.]
• Qualitative Questionnaire [Time frame: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.]
• Psychosocial Impact of Assistive Devices (PIAD) [Time frame: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface]

Secondary outcome measures (6)

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) [Time frame: Day 1]
• Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) [Time frame: Day 1]
• Clinical Evaluation [Time frame: Day 1]
• Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Section GG [Time frame: Day 1]
• Edinburgh Cognitive and Behavioral ALS Screen (ECAS) [Time frame: Day 1]
• World Health Organization Quality of Life-BREF (WHOQOL-BREF) [Time frame: Day 1]

Eligibility criteria

Enrollment will involve three different cohorts, namely a cohort of healthy participant, a cohort of ALS/SCI participant who underwent the implant of an invasive BCI device, and a cohort of ALS/SCI participants without any implanted BCI device.

Below are listed the inclusion and exclusion criteria for each diagnostic group.

Spinal Cord Injury (SCI):

Inclusion criteria

• Age at or above 18 years old;
• Diagnosis of spinal cord injury, at the level of T1 or above levels (between C1 and T1);
• Ability to communicate independently or with a support device, or with a legal representative;
• Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed.

Exclusion criteria

• Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.

Amyotrophic Lateral Sclerosis (ALS):

Inclusion criteria

• Age at or above 18 years old;
• Diagnosis of amyotrophic lateral sclerosis;
• Ability to communicate independently, with a support device, or with a legal representative;
• Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed.

Exclusion criteria

● Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.

Healthy Controls:

Inclusion criteria

• Age at or above 18 years old;
• No history of neurological or psychiatric disorders;
• Ability to provide written informed consent;
• Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed.

Exclusion criteria

• Participation in another trial that would conflict with the current study or clinical endpoint interference may occur;
• Cognitive, visual, or auditory deficits that would interfere with study participation;
• Current or prior diagnosis or condition that could confound study assessments.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Crossover

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Shirley Ryan AbilityLab — Chicago

Publications

• Sawyer A, Brannigan J, Spielman L; BCI Functional Outcome Measures Group; Putrino D, Fry A. Development of a novel clinical outcome assessment: digital instrumental activities of daily living. EBioMedicine. 2025 Jun;116:105732. doi: 10.1016/j.ebiom.2025.105732. Epub 2025 May 26. PMID 40424668
• Consortium for Spinal Cord Medicine. Outcomes following traumatic spinal cord injury: clinical practice guidelines for health-care professionals. J Spinal Cord Med. 2000 Winter;23(4):289-316. doi: 10.1080/10790268.2000.11753539. No abstract available. PMID 17536300
• Anderson K, Aito S, Atkins M, Biering-Sorensen F, Charlifue S, Curt A, Ditunno J, Glass C, Marino R, Marshall R, Mulcahey MJ, Post M, Savic G, Scivoletto G, Catz A; Functional Recovery Outcome Measures Work Group. Functional recovery measures for spinal cord injury: an evidence-based review for clinical practice and research. J Spinal Cord Med. 2008;31(2):133-44. doi: 10.1080/10790268.2008.1176070 PMID 18581660
• Pupillo E, Messina P, Giussani G, Logroscino G, Zoccolella S, Chio A, Calvo A, Corbo M, Lunetta C, Marin B, Mitchell D, Hardiman O, Rooney J, Stevic Z, Bandettini di Poggio M, Filosto M, Cotelli MS, Perini M, Riva N, Tremolizzo L, Vitelli E, Damiani D, Beghi E; EURALS Consortium. Physical activity and amyotrophic lateral sclerosis: a European population-based case-control study. Ann Neurol. 2014 M PMID 24706338
• Turner MR, Hardiman O, Benatar M, Brooks BR, Chio A, de Carvalho M, Ince PG, Lin C, Miller RG, Mitsumoto H, Nicholson G, Ravits J, Shaw PJ, Swash M, Talbot K, Traynor BJ, Van den Berg LH, Veldink JH, Vucic S, Kiernan MC. Controversies and priorities in amyotrophic lateral sclerosis. Lancet Neurol. 2013 Mar;12(3):310-22. doi: 10.1016/S1474-4422(13)70036-X. PMID 23415570
• Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371. PMID 15672628
• van Middendorp JJ, Hosman AJ, Donders AR, Pouw MH, Ditunno JF Jr, Curt A, Geurts AC, Van de Meent H; EM-SCI Study Group. A clinical prediction rule for ambulation outcomes after traumatic spinal cord injury: a longitudinal cohort study. Lancet. 2011 Mar 19;377(9770):1004-10. doi: 10.1016/S0140-6736(10)62276-3. Epub 2011 Mar 4. PMID 21377202
• Fessler EB, Brown RT, Miller RK. Rebooting Instrumental Activities of Daily Living for the 21st Century. Ann Intern Med. 2022 Feb;175(2):278-279. doi: 10.7326/M21-3065. Epub 2021 Dec 21. No abstract available. PMID 34928697

Identifiers

NCT: NCT07407725 · STU00224714

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗